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Zydus Lifesciences
Zydus Lifesciences on Friday said the US health regulator has granted Orphan Drug Designation to Desidustat, a novel oral product medication for the treatment of Sickle Cell Disease. The US Food and Drugs Administration's (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease. We believe that Desidustat can address this unmet need," Zydus Lifesciences MD Sharvil Patel said in a statement. Therapeutic options for management of Sickle Cell Disease are currently limited. A Phase II, double blind, randomised, placebo controlled, parallel, multi-centre, proof-of-concept study to evaluate the efficacy and safety of Desidustat oral tablet for treatment of SCD has been completed, and data will be published in a medical journal, the drug firm said. Orphan drug designation by
Zydus Lifesciences on Wednesday has received approval from the US health regulator to market a generic diabetes drug in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg, the drug firm said in a statement. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The company said the tablets will be manufactured at its formulation manufacturing facility at SEZ, Ahmedabad. As per the industry estimates, Dapagliflozin tablets had annual sales of USD 10,486.9 million in the US. Zydus shares on Wednesday ended 0.23 per cent up at Rs 905 apiece on BSE.
Zydus Lifesciences on Wednesday said it has launched a biosimilar for the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. The company has launched Zyrifa, a Denosumab biosimilar. Denosumab is a monoclonal antibody with several indications related to bone health, primarily in the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. This will provide access and treat patients with bone metastases due to breast, prostate, lung, myeloma, kidney, thyroid, head & neck, and other solid tumours, the Ahmedabad-based drug firm said in a regulatory filing. Metastases, is when the cancer spreads to the bones and other organs in the body indicating an advanced stage of cancer. The company said it has priced 'Zyrifa' at MRP of Rs 12,495. Sharvil P Patel, Managing Director, Zydus Lifesciences Ltd said that with Denosumab 120 mg SC, the company aims to bring access, affordability of medication in cancer patients ...
Zydus Lifesciences Ltd on Wednesday said it has entered into an exclusive licensing and commercialisation agreement with RK Pharma Inc of the US for a new sterile injectable oncology supportive care product for the US market. Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA (new drug application) submission and commercialisation of the product in the US, the company said in a regulatory filing. The product is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals, it added. "This partnership reinforces our commitment to delivering high-quality, affordable medicines and improving patient care," Zydus Lifesciences Managing Director Sharvil Patel said. RK Pharma Founder and Executive Chairman Ravishanker Kovi said, "Our collaboration with Zydus, a company with robust regulatory expertise and
Zydus Lifesciences on Thursday said the US health regulator has granted Orphan Drug Designation (ODD) to Desidustat, a novel product for the treatment of beta-thalassemia. The US Food and Drug Administration (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop Desidustat to address beta-thalassemia," Zydus Lifesciences MD Sharvil Patel said in a regulatory filing. Beta thalassaemia patients have low levels of haemoglobin, which results in a lack of oxygen in many parts of the body, leading to weakness, fatigue and more serious complications. Treatment for people with beta thalassaemia often requires lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) an